National drug regulation

The existence and functioning of a comprehensive drug regulatory system supported by legislation is a prerequisite for an overall quality assurance system. The first duty of a national regulatory authority is to register pharmaceutical products, thus defining the pharmaceutical market in the country. Only when this has been done will it be possible to distinguish between legally traded products and illegal and counterfeit ones.

The WHO Expert Committee on Specifications for Pharmaceutical Preparations addressed this issue in its thirty-first report and adopted guiding principles for small national drug regulatory authorities. These guiding principles, later endorsed by the World Health Assembly in resolution WHA47.17, are reproduced in Chapter 1. The text gives advice on how to organize national drug regulatory activities. The first section is devoted to general considerations such as the scope of drug control, basic responsibilities, licensing functions, product licences, manufacturers’ and distributors’ licences, new drug assessments, authorization of clinical trials, terms of reference of the regulatory authority, powers of enforcement, technical competence, advisory bodies and independence of operation.

The second and third sections of Chapter 1 address the administrative and technical aspects of the product registration or licensing process and give advice on the setting of priorities and on implementation by stages. It is anticipated that, once the initial drug registrations have been made, the registration process can be administered effectively if due advantage is taken of the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce, and prudence is exercised when accepting new chemical entities. It is recommended that developing countries do not register a new chemical entity before it has been on the market for at least five years in a country with a sophisticated drug regulatory system that includes post-marketing surveillance, unless the chemical entity presents a real therapeutic advance in combating a major endemic disease. If this approach is respected, the major work of the registration process will be the pharmaceutical evaluation of products that have not been registered in the country of export or that have been produced locally.

In some countries with large public sector procurement of essential drugs, major challenges will be to coordinate drug registration and procurement, making sure that only duly registered products are purchased. This is the only way to take real advantage of favourably priced generic products. If the purchase of generic products is allowed regardless of their registration status, there is no guarantee of the products’ quality with regard to stability and bioavailability, since pharmacopoeial specifications do not necessarily address these features.

A model software package for computer-assisted drug registration has been developed by WHO’s Division of Drug Management and Policies in collaboration with the Health System Information Unit of the Pan American Health Organization, and has now been field-tested in several countries. It can be obtained from the Division of Drug Management and Policies, WHO, 1211 Geneva 27, Switzerland.